Food

FDA Food Safety Modernization Act (FSMA) & Foreign Supplier Verification Programs (FSVP)

The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

The FSMA rule for Importers of Food for Humans and Animals, called Foreign Supplier Verification Programs (FSVP), has been made final by the FDA, and the first compliance date begins on May 30, 2017.

The FDA Food Safety Modernization Act of 2011 mandates the creation of a food safety system in which the focus is on preventing contamination rather than primarily reacting to problems after they occur. The FSMA rules include those that require preventive controls for food facilities that manufacture/process, pack, and hold human and animal foods, and establish science-based standards for produce grown on farms.

These rules apply to domestic food producers and those in other countries who export to the United States. The import community will be most impacted by the Foreign Supplier Verification Programs (FSVP) rule, which requires FSVP importers to verify that the food they import meets U.S. safety standards. FSVP importers are required to develop, maintain, and follow an FSVP for each food imported, unless an exemption applies. The goal is to ensure that each food is produced in a manner that provides the same level of public health protection as the preventive controls and produce safety regulations, if applicable, and the food is not adulterated or misbranded with respect to allergen labeling.

Who Is Covered by the FSVP Rule?

The FSVP importer is the U.S. owner or consignee of the food offered for import (i.e., owns the food, has purchased it, or has agreed in writing to purchase it at the time of U.S. entry). If there is no U.S. owner or consignee at time of entry, the FSVP importer is the U.S. agent/representative of the foreign owner/consignee, as confirmed in a signed statement of consent. The key is that there be a FSVP importer in the United States who takes responsibility for meeting the FSVP requirements.

FDA Registration and FDA US Agent Requirement

Foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. are required to register with the US FDA and have an FDA US agent. The FDA US agent must either reside in the U.S. or maintain a business in the U.S. The agent must be able to communicate with FDA during normal business hours for routine and emergency communications, unless the facility designates a different emergency contact.

FDA US Agent & registration service:

• The appointment of FDA US Agent is a mandatory requirement for foreign company who wish to sell their food products in the United States.

• First time registration, modification, and/or renewal of your Food Facility Registration.

• Electronic Certificate of Registration.

• One year FDA US Agent Service.

• Provide documentation for your business partners (suppliers, customers, and importers) when they need to verify your facility registration status.

• Apply prior notice to US FDA when requested.

• Review food product labeling with FDA requirements when requested.

Food Facility Biennial Registration Renewal

Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d] requires food facilities that are required to register with FDA to renew such registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year.

FDA registration number

The U.S. FDA assigns a registration number to each registered food facility. The assignment of registration number does not denote the approval of your establishment or product by the FDA. The FDA registration number only recognizes that the establishment is registered with FDA. Any representation of FDA registration number on product labels or labeling which creates an impression of FDA approval is a misbranding of the product.

Certificate of Registration requested by sales channel (Such as on-line sellers, Amazon FDA certificate request, etc.)

U.S. FDA is not issuing a registration certificate nor does U.S. FDA recognize a registration certificate issued by private business.

Some internet retailers, such as Amazon, are asking for FDA registration certificate for marketing Food, Dietary supplement, Cosmetic, Drug, Medical Device products in the NorthCert issues certificate of registration for our clients after completing registration. Facilities may use this certificate to demonstrate their effective FDA registration with Amazon, etc.

Foreign business and governments may ask for FDA certificate for products exporting from the U.S. FDA issues a certificate of free sale also known as FDA export certificate, to US firms that manufacture food, dietary supplements, cosmetics, and food additives. The certificate indicates that the product is marketed in the U.S. or eligible for export and the manufacturer has no pending enforcement action before FDA. FDA does not issue certificate to products manufactured outside the U.S. and FDA is not required by law to issue a certificate of free sale, even though FDA is providing this service to domestic firms.

FDA Detention

– Medical Device, Food, Drugs and Cosmetics

The products detained by FDA are mostly due to non-compliance with FDA

regulations. NorthCert assists exporters and importers to meet regulation requirement and release the detained product.

FDA Detention of Food products

The common reasons of FDA food detention:

• The food facility is not registered with FDA.

• The food labeling does not comply with FDA regulations.

• The manufacturer doesn’t appoint a US Agent.

• The prior notice is not available or not properly applied.

• The food exporter/importer is not registered with FDA.

Compliance & Enforcement

To protect public health, the US FDA monitors domestic firms and the foods that they produce. FDA also has multiple initiatives for monitoring imported products and foreign firms exporting to the United States. FDA protects consumers from unsafe foods through:

• Research and methods development

• Inspection

• Sampling

• Recall

• Seizure

• Injunction

• Criminal prosecution

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Warning Letters

When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter.

Inspections

FDA helps keep food safe through inspections, including the Foreign Food Inspection Program and inspections of aircraft water systems.

Prior notice

Prior Notice is required before food shipments (including samples for trade shows, for consumption, and for animal feed) may enter the United States, unless the food is excluded from Prior Notice. FDA must electronically receive and confirm Prior Notice before a food shipment arrives at the first port of arrival in the US.

You can file Prior Notice within 15 days of port arrival. The deadline for submitting Prior Notice depends on the mode of transportation used for shipment. A Prior Notice Confirmation Number issued by FDA must accompany most shipments.

Other than NorthCert filing support, your custom broker will file a Prior Notice as part of their import clearance process. International parcel shippers may also provide this service when requested.

FDA Food & Dietary Supplement Labeling Requirements

The US FDA has provided guidance for food & dietary supplement labeling Requirements. The guidance represents the FDA’s thinking on the requirement. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. You can contact NorthCert staff to discuss more detail for labeling requirement. You can also contact the FDA staff responsible for implementing this guidance.

Some of the important events relating to the labeling of dietary supplements include:

The Nutrition Labeling and Education Act of 1990 amended the Federal Food, Drug, and Cosmetic Act (the act) in a number of important ways. Notably, by requiring that most foods, including dietary supplements, bear nutrition labeling.

The Dietary Supplement Health and Education Act of 1994 (the DSHEA) amended the act, in part, by defining “dietary supplements,” adding specific labeling requirements for dietary supplements, and providing for optional labeling statements.

Acidified & Low-Acid Canned Foods

FDA Regulations require commercial processors of shelf stable acidified foods and

low-acid canned foods in a hermetically sealed container to be sold in the United

States to register each establishment and file scheduled processes with the FDA

for each product, product style, container size and type and processing method

(21 CFR 108).

A low-acid canned food (LACF) is any food (other than alcoholic beverages) with a

finished equilibrium pH greater than 4.6 and a water activity greater than 0.85,

excluding tomatoes and tomato products having a finished equilibrium pH less

than 4.7.

An acidified food (AF) is a low-acid food to which acid(s) or acid food(s) are added

and which has a finished equilibrium pH of 4.6 or below and a water activity (aw)

greater than 0.85.

FDA Food Canning Establishment (FCE) Registration and Process Filings (SIDs)

All commercial processors of low-acid and acidified foods located in the United States and all processors in other countries who export low-acid canned food or acidified food products into the United States must register their processing plants with FDA. Also, manufacturers must file documentation with FDA for each process used in the production of foods subject to these requirements. These submissions are known as a “Process Filing” and each is assigned a unique “Submission Identifier” (SID). Wholesalers, importers, distributors, brokers, etc. are not required to register and file processes. However, they must ensure that processing firms they represent comply with all registration and process filing requirements.

Foreign Food Facility Inspection Program

The US FDA is increasing the number of routine inspections worldwide of foreign food facilities under the jurisdiction of the FDA that export to the United States (processors/manufacturers, packers/repackers, and holders of foods). This increase is mandated based on new requirements included in the FDA Food Safety Modernization Act (FSMA), as enacted by the U.S. Congress and signed into law by the President on January 4, 2011. FDA is also taking similar efforts with regard to domestic facilities to ensure that the U.S. food supply is safe.

Foreign food facility inspections are designed to:

• Identify potential food safety problems before products arrive in the United States.

• Determine the compliance status of facilities to FDA’s requirements and food safety standards.

• Help the agency make admissibility decisions when food products are offered for importation into the United States.

• Help ensure that food products under FDA’s jurisdiction meet U.S. requirements under the Federal Food, Drug, and Cosmetic Act.